A Phase IIA Study of MK0457 in Patients With Cancer of the Lung - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00290550

Purpose

This is a study to evaluate the effectiveness of an investigational drug in patients with cancer of the lung.

Condition	Intervention	Phase
Carcinoma, Non-Small-Cell Lung	Drug: MK0457	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	A Phase IIA Study Evaluating the Efficacy of MK0457 as a 5-Day Continuous Infusion in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Further study details as provided by Merck:

Primary Outcome Measures:

Efficacy of MK0457 as a 5 day infusion as measured by radiological exams at baseline and after every other cycle of treatment. After 3 post-treatment radiological assessments, response will be measured after every third cycle. [ Time Frame: 5 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability as measured by duration, intensity (grade) and time of onset of toxicity. [ Time Frame: 5 Days ] [ Designated as safety issue: Yes ]

Arms	Assigned Interventions
1 MK-0457	Drug: MK0457 IV infusion at 10 mg/m2/hour; 5-day continuous infusion every 21 days

Eligibility

Criteria

Inclusion Criteria:

Patients who are at least 18 years of age with cancer of the lung and who have had either no previous treatment or 1 previous treatment for advanced cancer of the lung. Certain other treatments may also be allowed (prior cytotoxic chemotherapy in the adjuvant setting)

Exclusion Criteria:

Patients who have had treatment with any investigational therapy within the past 30 days are not eligible.
Patients who have had a disease or medical condition that is not controlled will not be eligible.
Patients who are pregnant or breastfeeding are not eligible.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00290550

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2006_008, MK0457-006
Study First Received:	February 9, 2006
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00290550
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Advanced Non-Small Cell Lung Cancer
NSCLC

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009